FDA Approval Date definition

FDA Approval Date means the date on which the United States Food and Drug Administration grants Regulatory Approval of C2B8 for manufacture and sale in the United States.

FDA Approval Date means the date of receipt of FDA approval allowing for Patheon’s manufacturing, testing, and packaging for the Product from the Phase I Filling Space and Phase II Manufacturing Space.

FDA Approval Date means the date upon which any party receives FDA Approval.

Examples of FDA Approval Date in a sentence

• Should either Flexion or Patheon exercise its right to terminate this Agreement or the Manufacturing and Supply Agreement in its entirety (but not in the event of an expiration of this Agreement as set forth in Section 8.2) prior to the FDA Approval Date, then the Manufacturing and Supply Agreement, this Agreement and the Quality Agreement will concurrently and automatically terminate.

• This Agreement shall commence as of the Effective Date and, unless earlier terminated in accordance with the terms hereof, shall expire on the tenth (10th) anniversary of the FDA Approval Date (the “Initial Term”).

• If the FDA Approval Date has occurred, Borrower shall thereafter elect (at its option and at any time) and satisfy any one of the following performance covenants: (i) Performance Covenant A, tested at all times during the period such covenant is elected by Borrower, (ii) Performance Covenant B, tested at all times during the period such covenant is elected by Borrower, or (iii) Performance Covenant C, tested at the end of the applicable month during the period such covenant is elected by Borrower.

• Prior to the FDA Approval Date, the Parties shall enter into a mutually agreed upon quality agreement (“Quality Agreement”).

• For the purposes of this Section 9.5(a), “calendar year” shall mean each consecutive 12 calendar month period starting Effective Date up until 1st day of the month following FDA Approval Date (liability cap pro-rated for part calendar years) and thereafter each consecutive 12 calendar month period from 1st of the month following FDA Approval Date.

More Definitions of FDA Approval Date

FDA Approval Date means the date of receipt by Client of Regulatory Approval in the United States for Products Manufactured at the Manufacturing Suite.

FDA Approval Date means the date on which the Company shall have delivered evidence satisfactory to the Purchaser Agent that the FDA has approved maralixibat as a treatment for Alagille Syndrome with a label consistent with the label included in the New Drug Application for maralixibat submitted to the FDA on November 11, 2020 and with no BLACK BOX warnings and with orphan exclusivity, as determined by the Purchaser Agent in its good faith business judgment.

FDA Approval Date means the date on which the U.S. Food and Drug Administration approves the use of KRN 5500 for the parenteral treatment of painful, chronic, chemotherapy-induced peripheral neuropathy that is refractory to conventional analgesics.

FDA Approval Date has the meaning set forth in Section 2.03(a).

FDA Approval Date means the date of receipt of Marketing Authorization from the FDA for the use of the Shingles Product; provided such approval does not occur later than June 30, 2018.

FDA Approval Date means the date on which the United States Food and Drug

FDA Approval Date means the date on which the FDA grants all approvals necessary for Kedrion to market and sell Private Label Albumin Product and Private Label IVIG Product. In the event the FDA approves the marketing and sale by Kedrion of one of the two products before the other, the FDA Approval Date shall be the latter of those two approval dates.